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Brain Networks Implicated in Lifelong Premature Ejaculation Patients (LPE)

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ClinicalTrials.gov Identifier: NCT04850703
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Collaborators:
Dr. Alejandro Molina Cabeza
Susana Ferrandis Martinez
Information provided by (Responsible Party):
Moises Domingo, Spanish Foundation for Neurometrics Development

Study Description
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Brief Summary:
Using Brain Mapping and Cognitive ERPs, the investigatos have searched for a Brain Networks involved during Inhibitory Control in Lifelong Premature Ejaculation (LPE) participants. The investigators have designed a clinical trial comparing placebo with tDCS and blacebo group against Dapoxetine, studying the effects on LPE, as well as side effects and their medium and long-term duration.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Sexual Dysfunction Device: Transcranial Radom Noise Stimulation Drug: Take Dapoxetine Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls Phase 1 Phase 2

Detailed Description:

Lifelong premature ejaculation (LPE) is a very common male sexual dysfunction like erectile dysfunction. It produces great distress to sexual harmony and even fertility. Previous neurophysiology studies revealed an ejaculation-related control mechanism in the brain: left inferior frontal gyrus (IFG) activation during successful inhibition. If we use the left IFG as a seed, participants showed weaker resting-state functional connectivity (FC) activity, between the seed and two areas (left dentate nucleus (DN) and right frontal pole) compared with controls.

The main goal is to compare whether the brain biomarker only exists in participants with LPD and how it responds to treatment with Dapoxetine and with tDCS against the IFG networks and lDN, measuring the connectivity changes in these brain networks and FC.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation: Randomized Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking Description: 12 patients will be receive tRNS sham 10 sessions. 12 patients will take Dapoxetine, sham 10.
Primary Purpose: Treatment
Official Title: Comparative Study of the Clinical Response Between tDCS and Dapoxetine, Define a Very Effective Therapeutic Target, That Improves the LPE in the Medium Long Term
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : June 4, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex

Participants receive tRNS (weak currents < 2 mA) sessions at IFG brain cortex for 25 minutes 2 times a day 3 times per week during 3 weeks.

After 4 hours they end the last session, a new brain mapping is performed.

 Device: Transcranial Radom Noise Stimulation
tRNS against Dapoxetine in LPE patients
Other Name: tRNS
Active Comparator: Premature Ejaculation participants who take Dapoxetine
Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping
 Drug: Take Dapoxetine
Dapoxetine against tRNS in LPE patients
Sham Comparator: Placebo Group
Participants who do not take medication or receive tRNS sessions
 Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants
Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.
Controls
44 Healthy humans not clinically not diagnosed with LPD and withouth expression the LPE endophenotype. In this way, the investigators what would be the patients diagnosed clinically with LPE who present the endophenotype or neurophysiological biomarker of LPE.
 Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls
Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype


Outcome Measures
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Primary Outcome Measures :
  1. Wavelet Changes define Brain Biomarker of LPE [ Time Frame: 1 month ]
    The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes.

  2. EEG coherence comparing Dapoxetine against tRNS [ Time Frame: 2-3 months ]
    The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence.

  3. Adverse events comparing Dapoxetine against tRNS [ Time Frame: 2-3 months ]
    Report adverse events during the application of the protocol Dapoxetine / tRNS.


Secondary Outcome Measures :
  1. Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls [ Time Frame: 1 month ]
    Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in Dapoxetine group against controls.

  2. Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls [ Time Frame: 1 month ]
    Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in tRNS group against controls.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All of patients were diagnosed of Longlife Premature Ejaculation
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To be over 18 years old and less than 70 years
  • Best-practice diagnosed Longlife Premature ejaculation
  • Diagnosed since at least one years prior to enrollment.
  • No use drugs or medicines

Exclusion Criteria:

  • Serious visual and hearing loss
  • Brain injury following cranial trauma
  • Other neurological disorders like Parkinson, ME, headache, etc.
  • Birth trauma
  • Mental retardation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850703


Contacts
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Contact: MOISES AGUILAR-DOMINGO, PhD +447940810368 drmoisesaguilar@gmail.com
Contact: Susana Ferrandis Martinez, MD +34630501290 susana2devel@gmail.com

Locations
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Spain
Salud Valclinic Recruiting
Valencia, Spain, 46900
Contact: ALEJANDRO MOLINA-CABEZA, DR    +34661962068    almolca@gmail.com   
Contact: SUSANA FERRANDIS-MARTINEZ    +34630501290    susana2devel@gmail.com   
Sub-Investigator: MOISES AGUILAR-DOMINGO, PhD         
Sub-Investigator: CHRISTIAN NAYAR, MD         
Sponsors and Collaborators
Moises Domingo
Dr. Alejandro Molina Cabeza
Susana Ferrandis Martinez
Investigators
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Principal Investigator: Alejandro Molina Cabeza, MD Sexual Salud Valclinic
Study Director: Christian Nayar, MD Hereford Hospital
More Information
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Additional Information:

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Responsible Party: Moises Domingo, Sub Investigator, Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier: NCT04850703    
Other Study ID Numbers: 0104201UR
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Moises Domingo, Spanish Foundation for Neurometrics Development:
Brain Mapping
EEG
ERP
tDCS
tRNS
Dapoxetine
Lifelong premature ejaculation
 central inhibitory network function
inferior frontal gyrus
dentate nucleus
right frontal pole
Resting State Networks
Funtional connectivity
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders